Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis. (PRECISION)

VPIX Medical

Status and phase: Not yet enrolling; Phase 1

Conditions: Frozen Sections; Indocyanine Green; Brain Tumor

Treatments: Device: cCeLL In vivo; Drug: Indocyanine Green

Study type: Interventional

Funder types: Industry

Identifiers

NCT06867978

cCeLL_II_2024

Republic of Korea (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to demonstrate the non-inferiority of cCeLL compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovascular before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, which is then read and analyzed by trained-professional for intraoperative diagnosis. The comparison will be held by the device with the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. Both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged 18 years or older
• Patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection
• Patients who understand and have signed the informed consent form

The specimens used in this study must meet all of the following criteria:

• Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
• Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients

Exclusion criteria

• Patients undergoing multiple surgeries
• Patients with bacterial or viral infections
• Patients who develop allergic reactions to the investigational medical device
• Patients with a history of allergy to Indocyanine Green (ICG)
• Patients with iodine hypersensitivity
• Patients taking choleretic agents or rifampicin

Specimens meeting any of the following criteria will be excluded from this clinical trial:

• Specimens with unclear tumor presence or carcinoma diagnosis results based on the reference standard permanent section analysis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

cCeLL - In vivo Imaging

Experimental group

Description:

Participants diagnosed with brain tumors will receive an intravenous injection of Indocyanine Green (ICG) during surgery. The cCeLL - In vivo confocal laser fluorescence microscope will be used to capture real-time images of the tumor margins before tissue collection. Standard frozen section and permanent section analyses will then be performed for diagnostic comparison.

Treatment:

Drug: Indocyanine Green

Device: cCeLL In vivo